QA interview questions (with answers)
20 original QA interview questions with answers for Indian pharma freshers and candidates with up to 3 years of experience. Tap an option to check your answer, or open "Show answer".
1. What is a deviation in a GMP environment?
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Answer: B — A deviation is an unplanned (or unapproved) departure from an approved instruction, procedure or standard. A planned approved change goes through change control, and a failing test result is handled as an OOS.
2. Which of the following is the best description of CAPA?
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Answer: C — Corrective action removes the cause of an existing problem; preventive action removes the cause of a potential one. A good CAPA also includes a defined effectiveness check, not only closing the action on paper.
3. Why must a change be evaluated by QA before it is implemented?
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Answer: C — Change control exists so that impact on quality, validated state, documents and regulatory commitments is assessed before implementation. Documenting after the fact defeats its purpose.
4. What is the difference between OOS and OOT?
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Answer: A — OOT results are still within specification but behave unusually compared with historical data, so they act as an early warning. Both need to be evaluated, though the OOS pathway is more formal.
5. An analyst gets an OOS result. What should be done first?
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Answer: D — The first step is a documented Phase I laboratory investigation, keeping the original preparations where possible. Testing into compliance by repeated retesting is not acceptable.
6. During batch record review, which finding is a data integrity concern rather than a simple typing error?
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Answer: C — Corrections must be made with a single line through the original, so that it stays legible, plus the initials, date and reason. Obscuring the original entry hides what was recorded.
7. What does the "A" in ALCOA stand for?
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Answer: B — ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate. ALCOA+ adds Complete, Consistent, Enduring and Available.
8. How long must batch records generally be retained under the basic US and EU GMP requirements?
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Answer: A — 21 CFR 211.180(a) requires records to be kept at least 1 year after the batch expiry date. EU GMP Chapter 4 (section 4.11) requires 1 year after expiry or at least 5 years after QP certification, whichever is longer.
9. What is the main purpose of the Annual Product Quality Review (APQR)?
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Answer: B — APQR reviews batch, deviation, change, stability, complaint and trend data for a product to confirm the process is in control and to find where improvement or revalidation is needed.
10. Which statement about process validation is correct?
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Answer: D — Process validation demonstrates consistent performance across the lifecycle, from design through qualification to continued process verification. It does not replace routine controls.
11. What is the main purpose of cleaning validation?
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Answer: A — Cleaning validation demonstrates that the cleaning procedure reliably removes residues so that cross-contamination of the next product is controlled below justified limits.
12. Which is a typical element of a risk-based cleaning validation exercise?
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Answer: D — Health-based exposure limits and the batch sizes involved are used to calculate carry-over limits, supported by validated swab or rinse sampling and analytical methods.
13. ICH Q9(R1) describes quality risk management as a process. Which pair of activities belongs to it?
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Answer: A — The Q9 process includes risk assessment (identification, analysis, evaluation), risk control, risk communication and risk review. Q9(R1) also stresses reducing subjectivity and managing the level of formality appropriately.
14. What is the purpose of a self-inspection (internal audit) programme?
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Answer: C — Self-inspections are scheduled, documented and followed up by CAPA. Their value lies in finding and fixing problems proactively, not in assigning blame.
15. Which practice is acceptable for GMP documentation?
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Answer: B — Contemporaneous, attributable entries are basic GMP documentation practice. Pre-dating, signing for others and erasable entries all undermine reliability.
16. Which unit must approve investigation outcomes and changes that can affect product quality?
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Answer: D — The quality unit is responsible for approving and rejecting materials, procedures, changes and investigation outcomes that can affect product quality.
17. Which situation is most likely to be classified as a critical deviation?
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Answer: C — Classification depends on potential impact on patient safety, product quality or data integrity. An undetected sterility assurance failure could affect patient safety, so it would be critical. The classification scheme itself is an example in-house criterion.
18. What does the "+" in ALCOA+ add?
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Answer: A — ALCOA+ extends the five basic attributes with Complete, Consistent, Enduring and Available, covering the whole data life cycle.
19. What is the purpose of a batch record review before release?
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Answer: B — QA reviews the executed batch record, test results, deviations and OOS investigations to confirm compliance before disposition. Release without this review would not be GMP-compliant.
20. When is a root-cause investigation considered adequate?
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Answer: D — Tools such as 5-Why or fishbone are used to reach a supported cause. Defaulting to "human error" and retraining without evidence is a common inspection finding.